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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Queensland Health
Fish and Richardson
Cipla
Boehringer Ingelheim
McKinsey
Fuji
Johnson and Johnson
QuintilesIMS
Accenture

Generated: August 23, 2017

DrugPatentWatch Database Preview

Lenalidomide - Generic Drug Details

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What are the generic sources for lenalidomide and what is the scope of lenalidomide patent protection?

Lenalidomide
is the generic ingredient in one branded drug marketed by Celgene and is included in one NDA. There are twenty-seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lenalidomide has four hundred and seventy-six patent family members in forty-six countries.

There are eleven drug master file entries for lenalidomide. One supplier is listed for this compound.

Summary for Generic Name: lenalidomide

Tradenames:1
Patents:27
Applicants:1
NDAs:1
Drug Master File Entries: see list11
Suppliers / Packagers: see list1
Bulk Api Vendors: see list87
Clinical Trials: see list735
Patent Applications: see list508
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:lenalidomide at DailyMed

Pharmacology for Ingredient: lenalidomide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-003Jun 29, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-002Dec 27, 2005RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-004Jun 29, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-006Jun 5, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-001Dec 27, 2005RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-001Dec 27, 2005RXYesNo► Subscribe► SubscribeYY ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-004Jun 29, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-004Jun 29, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-005Dec 21, 2011RXYesNo► Subscribe► Subscribe ► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-006Jun 5, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: lenalidomide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-002Dec 27, 2005► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-003Jun 29, 2006► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-004Jun 29, 2006► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-003Jun 29, 2006► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-005Dec 21, 2011► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-001Dec 27, 2005► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-001Dec 27, 2005► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-004Jun 29, 2006► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-006Jun 5, 2013► Subscribe► Subscribe
Celgene
REVLIMID
lenalidomide
CAPSULE;ORAL021880-003Jun 29, 2006► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: lenalidomide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,056,103Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of certain leukemias► Subscribe
7,629,360Methods for the treatment of cachexia and graft v. host disease► Subscribe
7,874,984Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug► Subscribe
8,207,200Methods for treating multiple myeloma using 3-(4-amino-1-oxo-1,3-dihydroindol-2-yl)-piperidine-2,6-dione follow by autologous stem cell transplantation► Subscribe
6,767,326 Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug► Subscribe
7,959,566Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated► Subscribe
8,440,194Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of certain leukemias► Subscribe
8,193,219Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione► Subscribe
8,404,716Methods of treating myelodysplastic syndromes with a combination therapy using lenalidomide and azacitidine► Subscribe
6,476,052 Isoindolines, method of use, and pharmaceutical compositions► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: lenalidomide

Country Document Number Estimated Expiration
Australia780486► Subscribe
World Intellectual Property Organization (WIPO)2004043377► Subscribe
European Patent Office2305663► Subscribe
Canada2688695► Subscribe
Australia2003290652► Subscribe
Argentina062265► Subscribe
Spain2529190► Subscribe
Spain2351069► Subscribe
Canada2794297► Subscribe
Slovenia1505973► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: LENALIDOMIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00717Netherlands► SubscribePRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
2007 00054Denmark► Subscribe
0717Netherlands► SubscribePRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
2015Austria► SubscribePRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE; REGISTRATION NO/DATE: EU/1/13/850 20130805
C0056France► SubscribePRODUCT NAME: IENALIDOMIDE EVENTUELLEMENT SOUS LA FORME D?UN DE SES SELS D?ADDITION D?ACIDES; REGISTRATION NO/DATE IN FRANCE: EU/1/07/391/001 DU 20070614; REGISTRATION NO/DATE AT EEC: EU/1/07/391/001-004 DU 20070614
140Estonia► Subscribe
642Luxembourg► SubscribePRODUCT NAME: POMALIDOMIDE ET SES SELS, SOLVATES, HYDRATES OU STEREOISOMERES PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT (IMNOVID); FIRST REGISTRATION DATE: 20130805
90004-6Sweden► SubscribePRODUCT NAME: POMALIDOMIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS, SOLVATES, HYDRATES OR STEREOISOMERS THEREOF; REG. NO/DATE: EU/1/13/850 20130808
56/2007Austria► SubscribePRODUCT NAME: 1-OXO-2(2,6-DIOXOPIPERIDIN-3-YL)-4- AMINOISOINDOLIN, AUCH 3-(4'AMINOISOINDOLIN-1'-ON)- 1-PIPERIDIN-2,6DION GENANNT, GEGEBENENFALLS IN FORM EINES SAEUREADDITIONSSALZES
2015 00006Denmark► SubscribePRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. NO/DATE: EU/1/13/850 20130805
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Covington
Citi
Chinese Patent Office
Daiichi Sankyo
Express Scripts
US Department of Justice
Medtronic
Harvard Business School
Argus Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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ISSN: 2162-2639

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